Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease

NCT03635190 | Completed Results DMC FDA Device

• 1 other identifier: 010-055
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 13

Brief Summary

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Diseases; Peripheral Artery Diseases; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• Technical Success

  Defined as the ability of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤50% without adjunctive therapy.

  At the time of the index procedure, usually within one hour after starting the procedure

• Freedom From Major Adverse Events

  Primary safety endpoint is freedom from a composite of new onset major adverse events (MAE) at 30-day follow-up as adjudicated by an Independent Clinical Events Committee. This endpoint is evaluated on a per patient basis.

  30 days

Secondary Outcomes (7)

• Clinical Success

  At index procedure

• Procedure Success

  At index procedure

• Ankle Brachia, Index (ABI) Measured at Baseline, 30 Days and 6 Months

  30 days and 6 months

• Rutherford Classification

  30 days and 6 months

• Vascular Quality of Life Questionnaire (VascuQoL) Administered at Baseline, 30 Days and 6 Months

  Baseline, 30 days and 6 months

Study Arms (1)

Interventional

EXPERIMENTAL

Orbital Circumferential Atherectomy

Device: Orbital Circumferential Atherectomy

Interventions

Orbital Circumferential Atherectomy DEVICE

Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

Also known as: Orbital Atherectomy Atherectomy

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Subject is a candidate for percutaneous endovascular intervention for peripheral vascular disease in the lower extremity.
• Objective hemodynamic criteria that subject has a resting ankle-brachial index (ABI) ≤ 0.90 OR a resting toe-brachial index (TBI) of ≤ 0.80 OR ankle pressure of ≤70 mmHg.
• Clinical presentation of lifestyle limiting claudication, rest pain and/or ischemic wounds as characterized by Rutherford Classification 2, 3, 4, or 5.
• Disease is located in the common femoral, superficial femoral, popliteal, tibioperoneal, anterior tibial, posterior tibial, and/or peroneal arteries.
• De novo target lesion(s) with stenosis ≥70% by visual estimation and/or
• Lesion(s) treated by percutaneous transluminal angioplasty (PTA) and/or atherectomy ≥3 months prior with a restenosis ≥70% by visual estimation.
• Up to three lesions can be treated at the index procedure provided the cumulative total lesion length is ≤ 20 cm AND all lesions are in the same target leg.
• Target reference vessel diameter (proximal to and distal to target lesion) is 2 to 8 mm by angiographic visual estimation.
• At least one patent vessel run-off to the ankle or foot at baseline.
• The target lesion(s) can be successfully crossed with a commercially available 0.014" atherectomy guidewire without any complications during wiring procedure.
• Subject signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure.
• Subject must be excluded from participation in this study if any of the following criteria are met:

You may not qualify if:

• Is female with childbearing potential not taking adequate contraceptives or is currently breastfeeding.
• Target lesion is within a native graft or synthetic graft.
• Target lesion is an in-stent restenosis.
• Target lesion is a chronic total occlusion (CTO) with occlusion length greater than 10 cm and/or with wire crossed sub-intimally. CTO wire placement in true lumen must be confirmed via Intra-vascular ultrasound (IVUS) prior to enrollment.
• Subject has significant stenosis or occlusion of inflow tract (upstream disease) not successfully treated during the index procedure and prior to treatment of the target lesion.
• Intra-operative (intra-procedure) clinical or angiographic complication (other than non-flow limiting dissections) attributed to the use of a currently marketed device prior to introduction of the Cardio Flow atherectomy drive shaft.
• Evidence or history of aneurysmal target vessel.
• Clinical/angiographic evidence of distal embolization prior to intervention.
• History of an endovascular procedure or open vascular surgery on the index limb within 30 days prior to the index procedure. Endovascular procedure or open vascular surgery on the non-index limb cannot be staged within 2 weeks prior to the index procedure.
• Planned endovascular or surgical procedure prior to the subject's 30 day follow up.
• Signs and symptoms of systemic infection (temperature of ≥ 38.0° Celsius and/or white blood cell count (WBC) of ≥ 12,000 cells/µL) at the time of assessment; Note: If infection is adequately treated and controlled (temperature \< 38.0° C and WBC \< 12,000 cells/µL) patient may be enrolled.
• Unstable coronary artery disease or other comorbid condition(s) that, in the judgment of the physician precludes safe percutaneous intervention.
• Significant acute or chronic kidney disease with a creatinine level \> 2.5mg/dL and/or requiring dialysis.
• Evidence of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stoke within 2 months of index procedure.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.

Sponsors & Collaborators

• Cardio Flow, Inc.: lead
• Libra Medical: collaborator

Study Sites (13)

Orlando Heart and Vascular Institute

Altamonte Springs, Florida, 32714, United States

Location

Palm Vascular Center of Broward, LLC

Fort Lauderdale, Florida, 33312, United States

Location

Cardiovascular Research of North Florida, LLC

Gainesville, Florida, 32605, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Cardiology Partners Clinical Research Institute

Palm Beach Gardens, Florida, 33410, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Cardiovascular Institute of the South

Opelousas, Louisiana, 70570, United States

Location

Advanced Cardiac & Vascular Centers for Amputation Prevention

Grand Rapids, Michigan, 49525, United States

Location

Eastlake Cardiovascular, PC

Saint Clair Shores, Michigan, 48080, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Texas Tech University Medical Center

Lubbock, Texas, 79430, United States

Location

Orion Medical Research, LLC

Pasadena, Texas, 77505, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Michael J Kallok, PhD
• Organization: Cardio Flow, Inc.

mjkallok@cardioflow.net

16512531754

Study Officials

• Fadi Saab, MD

  Advanced Cardiac & Vascular Amputation Prevention Centers

  PRINCIPAL INVESTIGATOR

• Thomas P Davis, MD

  Eastlake Cardiovascular

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multi-center, non-randomized single-arm study

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: December 17, 2018
• Primary Completion: March 24, 2021
• Study Completion: October 13, 2021
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)